Title: Senior Scientist - BioAnalytical/Biologics Services
Location: Hayward, CA
Reports to: Sr Director of Biologics Services
Full-time
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical and biologics services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Senior Scientist as part of the Biologics Services group, supports PK, immunogenicity, and/or biomarker projects.
This position will perform as a PI and manage the overall planning, execution, and quality of assigned projects. This position will be responsible for meeting project quality, compliance requirements and timelines with the support of lab management.
This position will oversee and enforce junior scientists in day-to-day operations. The position is also the primary technical point of contact with clients and other counterparts within the organization.
Roles & Responsibilities:
- Perform as PI and manage the overall planning, execution, and quality of assigned projects, including method development, qualification, and validation.
- Perform testing supporting PK, immunogenicity and/or biomarker projects.
- Conduct study design, lab-testing, data analysis and PI review.
- Author and/or review test methods, study protocols, and other related documents.
- Be the primary person to meet project timelines, quality, and compliance requirements.
- Oversee and enforce junior scientists to perform the studies following FDA guidance, Frontage SOPs and general industrial practices.
- Assist junior scientists with troubleshooting and solving technical issues.
- Be the primary person for client communication for assigned projects. Participate in teleconferences and technical discussions. Provide weekly summary to the sponsors.
- Be responsible for maintaining laboratory operation.
- Other duties as assigned.
Education, Experience & Skills Required:
- PhD in biochemistry, biology, pharmaceutics, or related scientific discipline with 8+ years of related experiences
- MS / MA in biochemistry, biology, chemistry, pharmaceutics or related scientific discipline with 10+ years of related experience.
- Direct hand-on experience on ligand binding assay method development, qualification and validation are required.
- Direct experience on PK, ADA and/or biomarker assays are strongly recommended.
- 4+ years industrial experience preferred. CRO experience is strongly preferred.
- Working knowledge of GLPs and other regulatory and safety standards is strongly preferred.
- Excellent organization and planning skills.
- Technical communication skills and writing skills are required.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.